Photographer: Krisztian Bocsi/Bloomberg

Amgen Wins Ban on Sanofi’s Praluent Cholesterol Drug Sales

  • Judge issues order after upholding jury verdict Amgen won
  • Ban takes effect in 30 days to give Sanofi time to appeal

Amgen Inc. won a court ruling blocking rivals Sanofi and Regeneron Pharmaceuticals Inc. from selling their cholesterol-lowering drug Praluent in the U.S. because it infringes Amgen’s patents covering a rival treatment.

U.S. District Judge Sue Robinson in Delaware ordered Sanofi and Regeneron Thursday to halt Praluent sales for 12 years because the drug infringes patents on Amgen’s Repatha medication. The order is a setback for the losing drugmakers since analysts expected Praluent to generate $2 billion in sales by 2020.

Amgen shares rose 4.3 percent to $159.51 in late trading at 6:49 p.m. New York time. Regeneron shares fell 1.1 percent to $376.61 before trading was halted at 5:20 p.m.

Sanofi and Regeneron pledged to appeal the ruling, saying in a statement that “the best interests of patients will be greatly disserved by an injunction preventing access to Praluent."

The sales ban takes effect in 30 days to give the companies time to ask an appeals court to lift the order or to “encourage the parties to reach an appropriate business resolution,” the judge said in a seven-page order. Otherwise, the patents expire in 2029, according to Aude Gerspacher, an analyst with Bloomberg Intelligence. 

The “surprise” ban could mean significantly higher sales for Repatha, although there is still uncertainty if an appeal is pursued, Michael Yee, an analyst with RBC Capital Markets, said in a note to clients.  

Without the ban, Amgen would face a loss of contracts with insurers and other market advantages as well as “reputational harm,” Robinson said. The judge said that outweighed the benefit to consumers in having a new treatment on the market.

Billions Spent

“Both parties have spent billions of dollars and over a decade of work to bring their respective products to market,” she said.

Robinson also noted in the order that she felt like she was “between a rock and a hard place” -- between protecting the rights of a winning patent holder and the benefit to the public of having another drug on the market that can potentially help stave off heart attacks.

The order came two days after the judge rejected Sanofi’s request to overturn a jury verdict won by Amgen in March.

Of Americans age 40 and older, 28 percent take some kind of medicine to reduce cholesterol in their blood and protect themselves from associated cardiovascular disease, according to a 2012 National Center for Health Statistics report.

March Verdict

Amgen, based in Thousand Oaks, California, sought the sales ban after jurors in Wilmington, Delaware, found in March that its patents were valid and properly describe the medical technology involving the cholesterol-fighting antibodies.

Paris-based Sanofi and Tarrytown, New York-based Regeneron said in Thursday’s statement that they will appeal both the jury’s verdict and the judge’s sales ban order.

"We will continue to vigorously defend our case through the appeal process as we believe the facts and controlling law support our position," said Joseph LaRosa, Regeneron’s general counsel.

Sanofi and Regeneron conceded before the trial that they infringed Amgen’s patents, a common legal tactic allowing the drugmakers to focus on whether the patent should have been issued at all. The companies argued the patent exceeds the scope of Amgen’s original discovery, wrongfully giving it control over a new class of treatments.

Repatha and Praluent are used to inhibit a protein known as PCSK9 and help patients reduce so-called bad cholesterol. Both drugs were approved by the U.S. Food and Drug Administration in 2015, and the companies have been battling to secure exclusive deals with health insurers and pharmacy benefit managers.

Genetic Conditions

For now, use of the drugs is limited to those with genetic conditions or who can’t tolerate other cholesterol medications such as statins, many of which have cheap generic versions.

Analysts tout the cholesterol-lowering drugs as potential blockbusters, with Repatha estimated to bring in $1.08 billion in 2018, according to an average of 11 analyst forecasts compiled by Bloomberg.

Amgen argued in court filings that allowing its rival to continue selling the competing drug would cause irreparable harm to one of the world’s largest biotech companies.

The firm has suffered “harm to its reputation and business model -- in addition to unpredictable and increasing economic harm -- that cannot be addressed through money damages,” Amgen said in an April court filing.

Sanofi and Regeneron countered that banning Praluent sales would harm patients, who are able to take lower doses of the cholesterol drug than are available through Amgen’s medication.

“Removal from the market will cause significant public harm,” the drugmakers’ lawyers said in a May filing.

The case is Amgen Inc. v. Sanofi Inc., 14-1317, U.S. District Court, District of Delaware (Wilmington).

— With assistance by Susan Decker, and Christopher Yasiejko

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